MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BARREL BUR 6 FLUTE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375941000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was a breach in the sterile barrier.
Additional Manufacturer Narrative
Alleged failure: the packaging of the shaver blades was already open on one side when taken out of the box.The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes could be an inadequate adhesive application process, inadequate positioning into the primary package, shipping and handling damage, or improper environmental conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a breach in the sterile barrier.

• Brand Name: BARREL BUR 6 FLUTE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20488097
• Report Number: 0002936485-2024-00710
• Device Sequence Number: 14332563
• Product Code: GFA
• UDI-Device Identifier: 37613327054744
• UDI-Public: 37613327054744
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 0375941000
• Device Lot Number: 23310CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown